BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9489252 · Received December 18, 2019

    Report

    Report Number
    1024879-2019-02127
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 14, 2019
    Report Date
    February 6, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. BD ACKNOWLEDGES THE CUSTOMER'S EXPERIENCE REGARDING THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD TECHNICAL SERVICES PROVIDED TROUBLESHOOTING WITH THE CUSTOMER AND THEY REPORTED THAT THEY ARE CURRENTLY NOT HAVING ANY ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD POOR SEPARATION. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9172629. IT WAS REPORTED THAT THE SPECIMENS WERE REJECTED. 3 OF 3: DATE OF EVENT (B)(6) 2019. I RECEIVED THIS COMPLAINT ON FRIDAY EVENING. EVIDENTLY THE CUSTOMER IS NOT IN THE OFFICE UNTIL DEC 2. THE CUSTOMER SAYS THEY CENTRIFUGED THE TUBE BUT IT WAS RECEIVED UNSPUN. THE USER IS ADAMANT THAT THEY CHECK EACH SAMPLE. THE LAB PHOTOGRAPHED THE RECEIVED TUBES AND THE TUBES AFTER THEY SPUN IT. 03-DEC: RCVD AN EMAIL FROM THE CUSTOMER PROVIDING THE FOLLOWING INFORMATION: WAS THERE MULTIPLE PATIENT INVOLVEMENT? IF SO, PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH INCIDENT: YES - 3. WHAT IS THE DATE OF EVENT(S)? (B)(6) 2019. WAS THE TUBE MIXED PROPERLY AFTER THE COLLECTION? YES. THIS IS VERIFIED PRIOR TO SHIPMENT. HOW LONG WAS THE SAMPLE ALLOWED TO CLOT? 30 MINUTES. WE SET A TIMER. WAS FIBRIN PRESENT IN THE SERUM? UNSURE. WERE THE RECOMMENDED CENTRIFUGATION G-FORCE, TIME, AND TEMPERATURE OBSERVED? TEMPERATURE AND TIME ARE OBSERVED, BUT UNABLE TO ASSESS G-FORCE. WHAT IS THE CENTRIFUGATION RAMP-UP SPEED? I¿M NOT SURE OF G-FORCE OR RAMP-UP SPEED, BUT I HAVE ATTACHED A PICTURE OF THE CALIBRATION STICKER. I HOPE THAT INFORMATION IS PRESENT ON THE STICKER. WHEN WAS THE CALIBRATION OF THE CENTRIFUGE LAST CHECKED? JUNE 2019. WHAT TYPE OF CENTRIFUGE WAS USED- FIXED ANGLE OR SWING BUCKET? FIXED-ANGLE. WERE THE CENTRIFUGE SLEEVES BALANCED TO ASSURE PROPER PERFORMANCE? YES, ALWAYS. IS THE CENTRIFUGE TEMPERATURE CONTROLLED? NO. IF SO, TO WHAT TEMPERATURE IS IT SET? N/A. WHAT DID THE GEL BARRIER LOOK LIKE (SLANTED OR FLAT; COMPLETE OR PARTIAL; GEL ON THE WALLS; GEL REMAINING ON THE BASE OF THE TUBE)? SLANTED. WAS THERE A COMPLETE BARRIER? YES. DOES THE POOR BARRIER APPEAR IN ALL TUBES OR ONLY OCCASIONALLY? N/A. ARE THE TUBES BEING TRANSPORTED FROM ONE LOCATION TO ANOTHER, IF SO, BY WHAT MEANS (PNEUMATIC TUBE, ROBOT, HAND CARRIED, COURIER, GROUND VS. AIR)? HAND CARRIED BY UPS DRIVER. ARE TUBES BEING STORED AT ROOM TEMPERATURE AND AWAY FROM DIRECT SUNLIGHT THROUGHOUT THEIR DISTRIBUTION AND USE? YES. DOES THE PATIENT HAVE ABNORMALLY HIGH PROTEIN LEVELS (PROTEIN DISORDER)? NOT THAT WE HAVE BEEN TOLD AND WE DO ASK FOR MEDICAL HISTORY. WHAT WAS STORAGE CONDITIONS? IN A CUPBOARD AT ROOM TEMPERATURE. WHERE THEY STORED IN REFRIGERATOR PRIOR TO USE? THE TUBES ARE NOT KEPT IN THE REFRIGERATOR PRIOR TO USE. ARE UNUSED SAMPLES OF THE RELATED BATCH AVAILABLE FOR INVESTIGATION? IF SO, PLEASE PROVIDE A FULL SHIPPING ADDRESS AND I WILL PROVIDE YOU A PREPAID SHIPPING LABEL. IT HAS HAPPENED OVER A FEW MONTHS, SO WE CAN SEND YOU A FEW OF WHAT WE HAVE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD POOR SEPARATION. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9172629. IT WAS REPORTED THAT THE SPECIMENS WERE REJECTED. 3 OF 3: DATE OF EVENT (B)(6) 2019. I RECEIVED THIS COMPLAINT ON FRIDAY EVENING. EVIDENTLY THE CUSTOMER IS NOT IN THE OFFICE UNTIL (B)(6). THE CUSTOMER SAYS THEY CENTRIFUGED THE TUBE BUT IT WAS RECEIVED UNSPUN. THE USER IS ADAMANT THAT THEY CHECK EACH SAMPLE. THE LAB PHOTOGRAPHED THE RECEIVED TUBES AND THE TUBES AFTER THEY SPUN IT. (B)(6) RCVD AN EMAIL FROM THE CUSTOMER PROVIDING THE FOLLOWING INFORMATION: WAS THERE MULTIPLE PATIENT INVOLVEMENT? IF SO, PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH INCIDENT: YES - 3. WHAT IS THE DATE OF EVENT(S)? (B)(6) 2019. WAS THE TUBE MIXED PROPERLY AFTER THE COLLECTION? YES. THIS IS VERIFIED PRIOR TO SHIPMENT. HOW LONG WAS THE SAMPLE ALLOWED TO CLOT? 30 MINUTES. WE SET A TIMER. WAS FIBRIN PRESENT IN THE SERUM? UNSURE. WERE THE RECOMMENDED CENTRIFUGATION G-FORCE, TIME, AND TEMPERATURE OBSERVED? TEMPERATURE AND TIME ARE OBSERVED, BUT UNABLE TO ASSESS G-FORCE. WHAT IS THE CENTRIFUGATION RAMP-UP SPEED? I¿M NOT SURE OF G-FORCE OR RAMP-UP SPEED, BUT I HAVE ATTACHED A PICTURE OF THE CALIBRATION STICKER. I HOPE THAT INFORMATION IS PRESENT ON THE STICKER. WHEN WAS THE CALIBRATION OF THE CENTRIFUGE LAST CHECKED? (B)(6) 2019. WHAT TYPE OF CENTRIFUGE WAS USED- FIXED ANGLE OR SWING BUCKET? FIXED-ANGLE. WERE THE CENTRIFUGE SLEEVES BALANCED TO ASSURE PROPER PERFORMANCE? YES, ALWAYS. IS THE CENTRIFUGE TEMPERATURE CONTROLLED? NO. IF SO, TO WHAT TEMPERATURE IS IT SET? N/A. WHAT DID THE GEL BARRIER LOOK LIKE (SLANTED OR FLAT; COMPLETE OR PARTIAL; GEL ON THE WALLS; GEL REMAINING ON THE BASE OF THE TUBE)? SLANTED. WAS THERE A COMPLETE BARRIER? YES. DOES THE POOR BARRIER APPEAR IN ALL TUBES OR ONLY OCCASIONALLY? N/A ARE THE TUBES BEING TRANSPORTED FROM ONE LOCATION TO ANOTHER, IF SO, BY WHAT MEANS (PNEUMATIC TUBE, ROBOT, HAND CARRIED, COURIER, GROUND VS. AIR)? HAND CARRIED BY UPS DRIVER. ARE TUBES BEING STORED AT ROOM TEMPERATURE AND AWAY FROM DIRECT SUNLIGHT THROUGHOUT THEIR DISTRIBUTION AND USE? YES. DOES THE PATIENT HAVE ABNORMALLY HIGH PROTEIN LEVELS (PROTEIN DISORDER)? NOT THAT WE HAVE BEEN TOLD AND WE DO ASK FOR MEDICAL HISTORY. WHAT WAS STORAGE CONDITIONS? IN A CUPBOARD AT ROOM TEMPERATURE. WHERE THEY STORED IN REFRIGERATOR PRIOR TO USE? THE TUBES ARE NOT KEPT IN THE REFRIGERATOR PRIOR TO USE. ARE UNUSED SAMPLES OF THE RELATED BATCH AVAILABLE FOR INVESTIGATION? IF SO, PLEASE PROVIDE A FULL SHIPPING ADDRESS AND I WILL PROVIDE YOU A PREPAID SHIPPING LABEL. IT HAS HAPPENED OVER A FEW MONTHS, SO WE CAN SEND YOU A FEW OF WHAT WE HAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286621 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 9172629 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other